Abstract: An improved system and method for placing implantable medical devices (IMDs) such as leads within the coronary sinus and branch veins is disclosed. In one embodiment, a slittable delivery sheath and a method of using the sheath are provided. The sheath includes a slittable hub, and a substantially straight body defining an inner lumen. The body comprises a shaft section and a distal section that is distal to, and softer than, the shaft section. A slittable braid extends adjacent to at least a portion of one of the shaft section and the distal section. In one embodiment of the invention, the sheath further includes a transition section that is distal to the shaft section, and proximal to the distal section. The transition section is softer than the shaft section, but stiffer than the distal section.

Abstract: Methods and systems for positioning a leadless pacing device (LPD) in cardiac tissue are disclosed. A delivery device is employed that comprises a proximal end, a distal end and a lumen therebetween sized to receive the LPD. The LPD has a leadlet extending therefrom that includes a means to fixate the leadlet to tissue. The delivery device comprises an introducer to introduce the LPD into the lumen of the delivery device. The LPD is loaded in the distal end of the lumen of the delivery device. The leadlet extends proximally from the LPD while the fixation means extends distally toward the LPD. A LPD mover is configured to advance the LPD out of the delivery device. A leadlet mover is configured to advance the leadlet out of the lumen delivery device and cause the leadlet to engage with cardiac tissue.

Abstract: Methods and systems for positioning a leadless pacing device (LPD) in cardiac tissue are disclosed. A delivery device is employed that comprises a proximal end, a distal end and a lumen therebetween sized to receive the LPD. The LPD has a leadlet extending therefrom that includes a means to fixate the leadlet to tissue. The delivery device comprises an introducer to introduce the LPD into the lumen of the delivery device. The LPD is loaded in the distal end of the lumen of the delivery device. The leadlet extends proximally from the LPD while the fixation means extends distally toward the LPD. A LPD mover is configured to advance the LPD out of the delivery device. A leadlet mover is configured to advance the leadlet out of the lumen delivery device and cause the leadlet to engage with cardiac tissue.

Abstract: An improved assembly for securing an implantable medical device for retrieval from an implant site includes a plurality of snares, wherein distal openings of a first snare carrier lumen and a second snare carrier lumen have a pre-set offset established therebetween. First and second snare shafts, to which first and second snare loops are coupled, respectively, extend within the corresponding snare carrier lumens such that each loop is located in proximity to the corresponding distal opening of the lumen. The pre-set offset allows an operator to simultaneously position the snare loops around the device; and, when the operator retracts the snare shafts to collapse the snare loops until the loops fit snuggly around the device, the pre-set offset can help to align the device for retrieval.

Abstract: A tubular wall, which may be employed in a medical catheter or medical electrical lead, is formed by stranding together a plurality of polymer fibers and at least one metal filar, wherein the stranding forms a braid matrix of the polymer fibers and a coil of the metal filar interlaced therewith. Then, while the braid matrix secures a pitch of the coil, a polymer material is extruded around an entire length of the tubular wall, and, in some cases, the extrusion process causes the plurality of polymer fibers to melt and coalesce together with one another, while the pitch of the coil is maintained. Alternately, a reflow process, which follows extrusion, causes the polymer fibers to melt and coalesce along all, or just a discrete length of the tubular wall.

Abstract: An image guided navigation system for navigating a region of a patient which is gated using ECG signals to confirm diastole. The navigation system includes an imaging device, a tracking device, a controller, and a display. The imaging device generates images of the region of a patient. The tracking device tracks the location of the instrument in a region of the patient. The controller superimposes an icon representative of the instrument onto the images generated from the imaging device based upon the location of the instrument. The display displays the image with the superimposed instrument. The images and a registration process may be synchronized to a physiological event.

Abstract: A tool operable with a catheter in an interventional medical system retrieves a medical device from an implant site, wherein the device includes an attachment feature that forms an annular recess to be engaged by a lasso of the tool for snaring the device, and a distal-most sidewall of the catheter defines a receptacle into which the snared device is retrieved. A guide of the tool includes a sidewall defining a lumen in which the lasso extends for deployment out from a distal opening thereof, to snare and retrieve the implanted device. The sidewall establishes a radial offset between the guide lumen distal opening and the distal-most sidewall of the catheter, when the guide lumen distal opening and a distal opening of the receptacle are located in close proximity to one another, which radial offset is greater than a length of the annular recess formed by the device attachment feature.

Abstract: A catheter for delivering a medical device to an implant site within a receptacle of a distal-most portion thereof, includes a coiled spring member, which has one or more proximal turns, secured to a shaft proximal portion, one or more distal turns, secured to the distal-most portion, and a plurality of open-pitch turns that extend between the proximal and distal turns and are, preferably, pre-loaded by longitudinal compression prior to forming a sheath thereover. A deflection assembly pull wire extends through a lumen of the shaft proximal portion and alongside the plurality of open-pitched turns of the spring member, wherein a pull wire proximal end extends proximally out from a proximal opening of the lumen of the proximal portion and into a handle of the catheter, for coupling to a control member subassembly, and a pull wire distal end is secured to the shaft distal-most portion.

Abstract: A delivery tool of a system for deploying medical diagnostics and/or therapy includes a deployment member and a sheath. An elastic cantilever element secured to a tubular sidewall of the deployment member, in proximity to a distal opening of a lumen formed by the sidewall, is spring biased to extend outward from the sidewall. When the cantilever element is received within the sheath, a sheath sidewall pushes the cantilever element inward, against the spring bias thereof, and a radius of curvature of the cantilever element approximately conforms to that of an outer surface of the deployment member sidewall. A helical track for receiving passage of a medical device helix fixation element therein may extend around a perimeter of the deployment member lumen, wherein a distal terminal end of the track is located in close proximity to the distal opening and generally opposite a free end of the cantilever element.

Abstract: A fixation mechanism of an implantable medical device is formed by a plurality of tines fixedly mounted around a perimeter of a distal end of the device. Each tine may be said to include a first segment fixedly attached to the device, a second segment extending from the first segment, and a third segment, to which the second segment extends. When the device is loaded in a lumen of a delivery tool and a rounded free distal end of each tine engages a sidewall that defines the lumen, to hold the tines in a spring-loaded condition, the first segment of each tine, which has a spring-biased pre-formed curvature, becomes relatively straightened, and the third segment of each tine, which is terminated by the free distal end, extends away from the axis of the device at an acute angle in a range from about 45 degrees to about 75 degrees.

Abstract: Methods and systems for positioning a leadless pacing device (LPD) in cardiac tissue are disclosed. A delivery device is employed that comprises a proximal end, a distal end and a lumen therebetween sized to receive the LPD. The LPD has a leadlet extending therefrom that includes a means to fixate the leadlet to tissue. The delivery device comprises an introducer to introduce the LPD into the lumen of the delivery device. The LPD is loaded in the distal end of the lumen of the delivery device. The leadlet extends proximally from the LPD while the fixation means extends distally toward the LPD. A LPD mover is configured to advance the LPD out of the delivery device. A leadlet mover is configured to advance the leadlet out of the lumen delivery device and cause the leadlet to engage with cardiac tissue.

Abstract: An implantable medical device includes ventricular and atrial portions, and a flexible leadlet that extends therebetween. An open channel of the atrial portion, formed along a core thereof, is sized to receive the leadlet therein, when the leadlet is folded over on itself. An interventional medical system includes the device and a delivery tool; a tubular sidewall of the tool defines a lumen and has a tether extending therein. A slot formed in the sidewall extends proximally from an open end thereof, coincident with a distal opening of the lumen. When the atrial portion is contained within the lumen, a segment of the leadlet extends alongside the atrial portion; another segment of the leadlet, being folded over on itself, proximal to the atrial portion, has the tether engaged therewith. The slot may allow passage of the leadlet therethrough, when the atrial portion is positioned for deployment through the distal opening.

Abstract: An image guided navigation system for navigating a region of a patient which is gated using ECG signals to confirm diastole. The navigation system includes an imaging device, a tracking device, a controller, and a display. The imaging device generates images of the region of a patient. The tracking device tracks the location of the instrument in a region of the patient. The controller superimposes an icon representative of the instrument onto the images generated from the imaging device based upon the location of the instrument. The display displays the image with the superimposed instrument. The images and a registration process may be synchronized to a physiological event.

Abstract: This disclosure is directed to extra, intra, and transvascular medical lead placement techniques for arranging medical leads and electrical stimulation and/or sensing electrodes proximate nerve tissue within a patient.

Abstract: A tubular wall, which may be employed in a medical catheter or medical electrical lead, is formed by stranding together a plurality of polymer fibers and at least one metal filar, wherein the stranding forms a braid matrix of the polymer fibers and a coil of the metal filar interlaced therewith. Then, while the braid matrix secures a pitch of the coil, a polymer material is extruded around an entire length of the tubular wall, and, in some cases, the extrusion process causes the plurality of polymer fibers to melt and coalesce together with one another, while the pitch of the coil is maintained. Alternately, a reflow process, which follows extrusion, causes the polymer fibers to melt and coalesce along all, or just a discrete length of the tubular wall.

Abstract: A catheter for delivering a medical device to an implant site within a receptacle of a distal-most portion thereof, includes a coiled spring member, which has one or more proximal turns, secured to a shaft proximal portion, one or more distal turns, secured to the distal-most portion, and a plurality of open-pitch turns that extend between the proximal and distal turns and are, preferably, pre-loaded by longitudinal compression prior to forming a sheath thereover. A deflection assembly pull wire extends through a lumen of the shaft proximal portion and alongside the plurality of open-pitched turns of the spring member, wherein a pull wire proximal end extends proximally out from a proximal opening of the lumen of the proximal portion and into a handle of the catheter, for coupling to a control member subassembly, and a pull wire distal end is secured to the shaft distal-most portion.

Abstract: A reservoir of a system for deploying an implantable lead to an extravascular location delivers a flow of fluid through a lumen of one or both of a tunneling tool and an introducer of the system. In some cases, the tunneling tool includes a pressure sensor assembly for monitoring a change in a pressure of the flow through the lumen thereof. Alternately, or in addition, a flow-controlled passageway, through which the flow of fluid from the reservoir is delivered to the lumen of the introducer, includes a compliant chamber to hold a reserve of the fluid. Fluid from the reserve may be drawn into the lumen of the introducer as the tunneling tool is withdrawn therefrom. Alternately, the introducer may include a chamber located between two seals, wherein fluid that fills the chamber is drawn distally into the lumen of the introducer, as the tunneling tool is withdrawn therefrom.

Abstract: A delivery tool of a system for deploying medical diagnostics and/or therapy includes a deployment member and a sheath. An elastic cantilever element secured to a tubular sidewall of the deployment member, in proximity to a distal opening of a lumen formed by the sidewall, is spring biased to extend outward from the sidewall. When the cantilever element is received within the sheath, a sheath sidewall pushes the cantilever element inward, against the spring bias thereof, and a radius of curvature of the cantilever element approximately conforms to that of an outer surface of the deployment member sidewall. A helical track for receiving passage of a medical device helix fixation element therein may extend around a perimeter of the deployment member lumen, wherein a distal terminal end of the track is located in close proximity to the distal opening and generally opposite a free end of the cantilever element.

Abstract: A method for implanting a medical lead. The method includes advancing a tunneling tool posteriorly proximate the caudal end of the sternum toward a first location. The tunneling tool is advanced superiorly underneath the sternum through the anterior mediastinum from the first location to a second location cranial to the first location. A guidewire is advanced from the first location to the second location. A medical lead is slid along at least a portion of the guidewire, the medical lead at least substantially spanning the distance between the first location and the second location.

Abstract: A method and device for implanting a medical lead. The device includes an elongate shaft defining a major longitudinal axis and including a proximal end and a distal end. A necked portion coupled to and extending from the distal end is included, the necked portion defines a first thickness and a substantially planar surface, the necked portion being at least resiliently movable in a direction normal to the major longitudinal axis.